Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 May;36(5):1012-1018.
doi: 10.1038/s41433-021-01542-w. Epub 2021 May 10.

Extended real-world experience with the ILUVIEN® (fluocinolone acetonide) implant in the United Kingdom: 3-year results from the Medisoft® audit study

Clare Bailey  1 , Usha Chakravarthy  2 , Andrew Lotery  3 , Geeta Menon  4 , James Talks  5 ; Medisoft Audit Group
Affiliations

Extended real-world experience with the ILUVIEN® (fluocinolone acetonide) implant in the United Kingdom: 3-year results from the Medisoft® audit study

Clare Bailey et al. Eye (Lond). 2022 May.

Abstract

Background: This study aimed to assess the long-term effectiveness of the 0.2 μg/day fluocinolone acetonide (FAc) implant over ≥3 years for patients with diabetic macular oedema.

Methods: A retrospective audit of pseudo-anonymised data from patients with chronic diabetic macular oedema (cDMO) and treated with the FAc implant across 14 UK clinical sites. Safety and clinical effectiveness were measured.

Results: Two-hundred and fifty-six eyes had ≥3 years of follow-up (mean 4.28 years), during which a mean of 1.14 FAc implants were used per eye. Mean best-recorded visual acuity (BRVA) increased from 52.6 to 56.7 letters at month 3 and remained stable thereafter; this trend was also seen in pseudophakic eyes. The proportion of patients attaining a BRVA ≥6/12 increased from 17% at baseline to 27% 1 month after FAc implant and remained stable above 30% from month 12 onwards. Eyes with no prior history of intraocular pressure (IOP)-related events required significantly less treatment-emergent IOP-lowering medication than those with a prior history of IOP events (17.9% vs. 50.0% of eyes; p < 0.001). The incidence of an IOP increase of ≥10 mmHg, use of IOP-lowering medication, laser trabeculoplasty and IOP-lowering surgery was 28.9%, 29.7%, 0.8% and 2.7%, respectively, for the whole cohort. There were significant reductions in mean central foveal thickness and macular volume (p < 0.001).

Conclusions: The FAc implant was well tolerated, with predictable and manageable IOP-related events while delivering a continuous microdose of corticosteroid to eyes with cDMO, providing prolonged vision preservation and a reduced number of treatments.

PubMed Disclaimer

Conflict of interest statement

CB is a consultant for Bayer, Alimera Sciences, Roche and Novartis. UC is a consultant for Allergan, Bayer, Novartis, Alimera Sciences and Roche. AL is a consultant for Bayer, Roche and Gyroscope Therapeutics. GM is a consultant for Novartis and Bayer. JT is a consultant for Bayer, Alimera Sciences, Allergan and Novartis.

Figures

Fig. 1
Fig. 1. BRVA for all eyes (shown in both the figure and the table) and pseudophakic eyes (shown in the table only) over 48 months.
Error bars represent SEM (Mean) or SE (Median). BRVA best-recorded visual acuity, SE standard error, SEM standard error of the mean, VA visual acuity.
Fig. 2
Fig. 2. BRVA outcomes for all eyes over 48 months.
Proportion of eyes (a) gaining 1, 2 or 3 lines of improvement in BRVA and (b) achieving ≥6/12 vision BRVA best-recorded visual acuity, VA visual acuity.
Fig. 3
Fig. 3. Impact of prior IOP-related events.
aTime-to-event analyses were not performed for laser trabeculoplasty or IOP-lowering surgery, as the number of events was very small, and the data could have been significantly skewed by outliers. IOP intraocular pressure, SD standard deviation.
See this image and copyright information in PMC

References

    1. Estebainha R, Goldhardt R, Falcão M. A new approach for diabetic macular edema treatment: review of clinical practice results with 0.19 mg fluocinolone acetonide intravitreal implant including vitrectomized eyes. Curr Ophthalmol Rep. 2020;8:1–10. doi: 10.1007/s40135-020-00225-1. - DOI - PMC - PubMed
    1. Daien V, Eldem BM, Talks JS, Korobelnik J-F, Mitchell P, Finger RP, et al. Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy—a systematic approach to identify and characterize data sources. BMC Ophthalmol. 2019;19:206. doi: 10.1186/s12886-019-1208-9. - DOI - PMC - PubMed
    1. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419–31. doi: 10.1056/NEJMoa054481. - DOI - PubMed
    1. McCluskey JD, Kaufman PL, Wynne K, Lewis G. Early adoption of the fluocinolone acetonide (FAc) intravitreal implant in patients with persistent or recurrent diabetic macular edema (DME) Int Med Case Rep J. 2019;12:93–102. doi: 10.2147/IMCRJ.S191171. - DOI - PMC - PubMed
    1. Bressler NM, Beaulieu WT, Glassman AR, Blinder KJ, Bressler SB, Jampol LM, et al. Persistent macular thickening following intravitreous aflibercept, bevacizumab, or ranibizumab for central-involved diabetic macular edema with vision impairment: a secondary analysis of a randomized clinical trial. JAMA Ophthalmol. 2018;136:257–69. doi: 10.1001/jamaophthalmol.2017.6565. - DOI - PMC - PubMed